BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIR ON RANGER

    MDR report key: 190067 · Received September 28, 1998

    Report

    Report Number
    6000060-1998-00061
    Event Type
    Injury
    Date Received
    September 28, 1998
    Date of Event
    August 28, 1998
    Report Date
    August 31, 1998
    Manufacturer
    SCIMED LIFE SYSEM, INC./A SUBSIDIARY OF BOSTON SCIENTIFIC CORP
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENT PROCEDURE, THE PHYSICIAN HAD DIFFICULTY CROSSING THE LESION DURING PLACEMENT OF A SECOND STENT. WHILE ATTEMPTING TO REMOVED THE SYSTEM, THE STENT BECAME DISLODGED. THE STENT WAS RETRIEVED USING A SNARE. THE PT STATUS IS REPORTED AS "OKAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIR ON RANGER Implant CORONARY STENT DELIVERY SYSTEM MAF SCIMED LIFE SYSEM, INC./A SUBSIDIARY OF BOSTON SCIENTIFIC CORP NRGR 25/3.0 1395910

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention CORONARY STENT - 8/28/98